Epygenix Therapeutics has submitted an investigational new drug application (IND) to the FDA to assess the safety and efficacy of EPX-100, its investigational therapy for Dravet syndrome.
If accepted, Epygenix expects to initiate a Phase 1 trial with healthy volunteers by August. The company has also requested fast track designation for EPX-100.
A new drug application is an essential first step in launching a clinical trial; a fast track designation allows for an accelerated FDA review process for treatments that could alleviate serious conditions and fill an unmet medical need.
“This IND filing for EPX-100 is one of the company’s significant development milestones. We will test its safety and efficacy in a prompt manner with an eye toward helping many patients who suffer from this disorder,” Hahn-Jun Lee, M.Sc., PhD, president and CEO of Epygenix Therapeutics, said in a press release.
“We are very pleased to collaborate with Epygenix to support the IND filing for EPX-100, as well as to manage the Phase 1 study in normal volunteers,” said Jules Mitchel, PhD, president at Target Health, the lead regulatory and clinical research organization for the EPX-100 development program.
EPX-100 is a repurposed antihistamine, originally known as clemizole, used to treat itching in the 1950s and 1960s. EPX-100 has shown potential to suppress seizures by modulating serotonin, a mechanism that differs from its antihistaminic properties.